EU Regulatory Update - changes and pending revisions to regulatory guidance documents
There are pending revisions to the NB-MED 2.5.2 Recital 2 on "Substantial" or "Significant" Change. What does this mean for manufacturers? In particular, the new guidance clarifies the reporting of design changes and changes of the quality system to Notified Bodies. Additionally, and in part two of this newsletter, revision of the GHTF Guidelines Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers, Part 4 and 5, has just been published. Finally, we will also discuss a recent meeting of The Competent Authorities for Medical Devices (CAMD) Network.
NB-MED 2.5.2 Recital 2 on "Substantial" or "Significant" Change - Version 8 Forthcoming
As a reminder, NB-MED refers to the Co-ordination of Notified Bodies Medical devices on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC. The new guidance, which will soon be made publically available, will be the 8th version of the document. The Guidance has not been amended since 2000.
This concept is of importance because it was not defined in the directives. The issue is that the terms "substantial" and "significant" regarding when changes must be reported to Notified Bodies are used interchangeably throughout the Directives (MDD, IVDD, and AIMDD). Thus, the guidance aims to provide clarification for manufacturers as to what constitutes a reportable change.
A salient difference between the new and old version of the Guidance are the examples of what should be reported to a Notified Body. The new version provides several scenarios in which the changes are considered reportable; both to the quality system and to the EC approved medical devices design/type.
When the new guidance is published, we recommend that clients review the section on NB-MED recommended questions which manufacturers should ask themselves when assessing whether or not the Notified Body should be notified. A subsequent question, does the manufacturer's procedures on the topic need to be modified?
GHTF Guidelines on Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Parts 4 and 5 Revised
In addition to the pending release of Revision 8 of the NB-MED Guidance on Substantial Change, the GHTF has recently revised its Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. In particular new revisions of Parts 4 and 5, Audits of Manufacturer Control of Suppliers, respectively, were issued on 30 September 2010.
The Competent Authorities for Medical Devices (CAMD) Network for Medical Devices
Just recently, the Competent Authorities established CAMD, a voluntary network to improve communication amongst them. CAMD aims to discuss the state of affairs and anticipate future legislation of medical devices. At the end of September, CAMD met in Belgium to discuss: the creation of a Central Management Committee for increased and agreed upon regulatory harmonization; reprocessing medical devices for single use; IVDs; and the recast and revision of the medical devices regulations (directives 93/42/EEC, 90/385/EEC and 98/79/EC). As information from this organization is disseminated, we'll be sure to communicate any newsworthy comments at that time.
Reminder to consider risks of machinery
Of noteworthy comment, it is crucial that manufacturers of products that are both medical devices and machinery, consider the risks in machinery also. The Essential Safety and Health Requirements (Annex I) of the Machinery Directive 2006/42/EC would need to be reviewed to determine if there were hazards relevant to medical devices. The EU Commission indicated that "if the corresponding essential health and safety requirement of Directive 2006/42/EC is either not provided for in Annex I of Directive 93/42/EEC ... or is more specific than the essential requirements of the applicable Medical Devices Directive, the essential requirement of Directive 2006/42/EC will have to be met by the medical device concerned." Thus, the relevant machinery hazards that are not included or more specific than the Essential Requirements in the MDD, will need to be addressed.